Ticino Artificial InTelligence integrAtioN for Occlusion Myocardial Infarction

Обзор

The goal of this clinical trial is to evaluate whether an artificial intelligence (AI)-based ECG interpretation tool improves the early diagnosis and treatment of occlusion myocardial infarction (OMI) in adults presenting with suspected acute coronary syndrome (ACS) who do not meet traditional ST-elevation myocardial infarction (STEMI) criteria. The main questions it aims to answer are: 1. Does AI-assisted ECG interpretation enable more timely identification and treatment of OMI, as defined by earlier initiation of coronary intervention? 2. Does AI-assisted diagnosis reduce infarct size, measured by peak high-sensitivity troponin T (hsTnT) levels? Researchers will compare AI-assisted ECG interpretation to standard care to determine if the AI tool improves clinical outcomes and care timelines. Participants will: 1. Present with symptoms suggestive of ACS but without clear STEMI criteria 2. Be randomized 1:1 to either AI-assisted or standard ECG interpretation 3. Undergo follow-up assessments for cardiovascular outcomes, including 30-day death, time to treatment of total coronary occlusion, and peak hsTnT levels

Вмешательства

• Диагностический тест AI-assisted ECG interpretation (PMcardio)
  Participants in the experimental arm will undergo 12-lead ECG interpretation supported by a CE-marked artificial intelligence (AI) tool (PMcardio, Powerful Medical, Slovakia). The AI algorithm analyzes ECG data in real time to detect patterns suggestive of occlusion myocardial infarction (OMI), including cases not meeting traditional ST-elevation myocardial infarction (STEMI) criteria. In the experimental arm, the AI output is provided immediately to the treating clinician and used as an adjunct

Первичные конечные точки

• Hierarchical primary endpoint [Срок оценки: 30 days]

Вторичные конечные точки (12)

• Cardiovascular mortality at 30 days [Срок оценки: 30 days]
• Timely treatment of TIMI 0-1 occlusions [Срок оценки: Periprocedural]
• Time-to-treatment of TIMI 0-1 occlusions [Срок оценки: Periprocedural]
• Peak hsTnT levels [Срок оценки: 48 hours from randomization or intervention]
• Major adverse cardiovascular events (MACE) at follow-up [Срок оценки: up to 10 years]
• Cardiovascular death at follow-up [Срок оценки: up to 10 years]
• Myocardial infarction at follow-up [Срок оценки: up to 10 years]
• Stroke at follow-up [Срок оценки: up to 10 years]
• Infarct Size [Срок оценки: 48 hours from randomization or intervention]
• Infarct Size [Срок оценки: 48 hours from randomization or intervention]
• Infarct Size [Срок оценки: 48 hours from randomization or intervention]
• Time from randomization to antithrombotic therapy [Срок оценки: periprocedural]

Критерии участия

Критерии включения

• Symptoms suspected of ongoing acute myocardial ischemia: Patients presenting with symptoms such as chest pain, dyspnoea, sweating, nausea or vomiting, pain radiating to the shoulder/arm/jaw/back, fatigue, or light-headedness
• Age: Patients aged 18 years or older.
• Informed Consent: Patients able to provide informed consent

Критерии исключения

• Clear diagnosis of ST-segment elevation MI (STEMI) according to managing physicians.
• Pregnancy or Lactation.
• Legally incompetent to provide informed consent.
• Symptoms onset>24 hrs prior to clinical presentation.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Диагностика

Центры проведения

Швейцария · 1 центр

• Cardiocentro Ticino Institute — Lugano

Идентификаторы

NCT: NCT07077057 · 2024-01655

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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